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Diss Factsheets
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EC number: 236-068-5 | CAS number: 13138-45-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- chronic toxicity: inhalation
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study (OECD 453)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Comparative Carcinogenic Effects of Nickel Subsulfide, Nickel Oxide, or Nickel Sulfate Hexahydrate Chronic Exposures in the Lung
- Author:
- Dunnick JK, Elwell MR, Radovsky AE, Benson JM, Hahn FF, Nikula KJ, Barr EB, Hobbs CH
- Year:
- 1 995
- Bibliographic source:
- CANCER RESEARCH. 55: 5251-5256
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Deviations:
- not specified
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Nickel sulphate
- EC Number:
- 232-104-9
- EC Name:
- Nickel sulphate
- Cas Number:
- 7786-81-4
- Molecular formula:
- NiSO4
- IUPAC Name:
- nickel(2+) sulfate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: F344/N
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Farms, Germantown, NY
- Housing: Hazleton 2000 whole-body chambers
- Diet (e.g. ad libitum): ad libitum during non-exposure periods
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hr dark, 12 hr light
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: no data
- Remarks on MMAD:
- MMAD / GSD: MMAD =2.08-2.52 um
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Hazieton 1000 (mice) and Hazleton 2000 (rats) whole-body chambers (Lab Products, Inc., Maywood, NJ)
- Method of holding animals in test chamber: not reported
- Source and rate of air: not reported
- Method of conditioning air: not reported
- System of generating particulates/aerosols: Nickel sulfate aerosols were generated by nebulization of nickel sulfate solutions
- Temperature, humidity, pressure in air chamber: not reported
- Air flow rate: not reported
- Air change rate: not reported
- Method of particle size determination: Aerosol concentration was determined by taking three 2-h filter samples throughout the exposure day.
Real-time determination of aerosol concentration was made using real time aerosol monitor - model S units. Aerosol size was determined using cascade impactors. (The range of mass median aerodynamic diameters and GSD obtained throughout the study were 2.2-2.5 um and GSD=2.2)
- Treatment of exhaust air: not reported
TEST ATMOSPHERE
- Brief description of analytical method used: Aerosol concentration was determined by taking three 2-h filter samples throughout the exposure day.
Real-time determination of aerosol concentration was made using real time aerosol monitor - model S units. Aerosol size was determined using cascade impactors. (The range of mass median aerodynamic diameters and GSD obtained throughout the study were 2.2-2.5 um and GSD=2.2)
- Samples taken from breathing zone:not reported
VEHICLE (if applicable)
- water - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Aerosol concentration was determined by taking three 2-h filter samples throughout the exposure day.
Real-time determination of aerosol concentration was made using real time aerosol monitor-model S units. - Duration of treatment / exposure:
- 6 hr/day
- Frequency of treatment:
- 5 d/wk, 2 yr
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.125, 0.25, 0.5, 1.0 mg/m3
Basis:
nominal conc.
- No. of animals per sex per dose:
- Groups of 63 to 65 male and 63 to 64 female rats
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: based on previous 13-week study
- Positive control:
- Not applicable
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: every 4 weeks
BODY WEIGHT: Yes
- Time schedule for examinations: every 4 weeks
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION: No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: No data
CLINICAL CHEMISTRY: No data
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: No data
OTHER: Lung Ni burden - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, organ weights
HISTOPATHOLOGY: Yes. Complete histopathology was performed on high-exposure and control groups and to a no-effect level in target tissues. - Other examinations:
- lung Ni concentration
- Statistics:
- Tests of significance included pairwise comparisons of each exposed group with controls and a test for overall exposure-related trends. Organ and body weight data were analyzed using parametric multiple comparison procedures, and lung burden data were analyzed using nonparametric multiple comparison methods. The reported values were considered significant at the P < 0.05 level.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Details on results:
- GROSS PATHOLOGY/HISTOPATHOLOGY:
Complete necropsies were done on all animals. At necropsy, all organs and tissues were examined for grossly visible lesions, and all major
tissues and lesions were preserved in 10% neutral-buffered formalin, embed ded in paraffin, sectioned, and stained with hematoxylin and
eosin for microscopic examination.
Additional animals were added for lung burden determinations at 7 or 15 months, Ni analyzed by atomic absorption spectroscopy.
MORTALITY & BODY WEIGHT:
Survival and body weights were similar to in exposed mice and rats to controls.
ORGAN WEIGHTS:
At 15-months, the lung weight in the high-exposure nickel sulfate mice was 30-37% more than control lung weight, and in the rats, 33-41% more than controls.
GROSS & HISTOPATHOLOGY:
A spectrum of exposure-related nonneoplastic respiratory tract lesions included: focal alveolar/bronchiolar hyperplasia, inflammation, and/or
fibrosis of the lung and lymph oid hyperplasia of the lung-associated lymph nodes, and atrophy of the olfactory epithelium.
There were no increases in lung neoplasms in rats or mice exposed to nickel sulfate. The A/B neoplasms that were observed in the exposed
groups were similar in incidence and morphology to those observed in controls.
OTHER FINDINGS:
The lung burden at 7 or 15 months in rats and mice was 1-2 ug Ni/g lung for nickel sulfate.
Effect levels
open allclose all
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 0.027 other: mg Ni/m3 (as Ni sulfate hexahydrate)
- Sex:
- male/female
- Basis for effect level:
- other: chronic active lung inflammation
- Dose descriptor:
- LOAEC
- Effect level:
- 0.056 other: mg Ni/m3 (as Ni sulfate hexahydrate)
- Sex:
- male/female
- Basis for effect level:
- other: Chronic active lung inflammation
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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